MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)

Multiple Sclerosis Clinical Trial

— MOVING  

Official title:

Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01647880
• Other study ID #: MOVING
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of relapsing-remitting multiple sclerosis (RRMS)

• ability to consent and a written approval

• First acute ON attack to the fit eye within 30 days before screening

• Age 18 - 55 years at screening

• EDSS = 6.0

• No MS Attack except for ON in the last 30 days before screening

• No immunomodulatory therapy for at least three Months (before randomization), or

• strong immunomodulatory therapy with interferon beta or glatiramer acetate for at least 6 months

• visus in the affected eye at least 0.1

• latency of Conventional VEP in the affected eye

• = 115 ms or difference> = 15 ms to the opposite side at a Study at least 4 but no more than 6 weeks after Onset of clinical symptoms

• At least 2 T2 lesions typical of MS in a previous MRI

Exclusion Criteria:

• other MS course than RRMS

• any condition which could interfere or prevent the MRI study or other investigations

• known allergy or intolerance, or other contraindication against Gd-DTPA

• Patients with known contraindications to treatment with fingolimod (Gilenya ®) or interferon beta-1b Extavia ®

• Competing diseases which could affect visual functions such as diabetic, retinopathy, glaucoma, retinal detachment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuritis
• Optic Neuritis

Intervention

Drug:
• Verum arm receiving Gilenya®

• Active Comparator receiving Extavia®

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin	Berlin
Germany	Sankt Josefs Krankenhaus Potsdam Neurologie	Potsdam

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy parameters	Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline
Secondary	Efficacy parameters	Decrease in the latency of the mVEP from the affected eye at the time points 1, 3 and 12 months in comparison to baseline. Retinal nerve fiber layer thickness and macular volume in OCT, visual contrast sensitivity, visual field, Color vision, visual quality of life, in CMRT lesion load in cMRT , neurotrophic factors and axonal damage markers (neurofilament) and neurotrophins (for example, BDNF) in the serum